Otto Bock 4R11 Quickchange User manual

Instructions for use ................................................................................................................ 7
4R11 Quickchange

4R11=P-1-14R11=R-1-14R11=ST-1-14R11=ST-2-14R11=R-3-2
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1 Product description English
INFORMATION
Date of last update: 2023-07-04
►Please read this document carefully before using the product
and observe the safety notices.
►Instruct the user in the safe use of the product.
►Please contact the manufacturer if you have questions about the
product or in case of problems.
►Report each serious incident related to the product to the manu
facturer and to the relevant authority in your country. This is par
ticularly important when there is a decline in the health state.
►Please keep this document for your records.
1.1 Construction and Function
The 4R11 Quickchange adapter makes it possible to quickly change
prosthetic components without tools. The adapter consists of a base
and various connectors that are plugged together and locked into
place.
1.2 Combination possibilities
This prosthetic component is compatible with Ottobock's system of
modular connectors. Functionality with components of other manufac
turers that have compatible modular connectors has not been tested.
Limited combination options
•Connect to a pyramid of the modular system for children:
Insert reducer 4X907=1 into the pyramid receiver of the
Quickchange adapter base.
•Combination with the foot adapter 2R40=1: Do not connect
the Quickchange adapter directly to the foot adapter.
2 Intended use
2.1 Indications for use
The product is intended exclusively for lower limb exoprosthetic fit
tings.
2.2 Area of application
Product approved for max. body weight
• The maximum approved body weight is specified in the technical
data (see page11).
2.3 Environmental conditions
Storage and transport
Storage temperature: -20°C to +60°C, relative humidity: 20% to
90%, no mechanical vibrations or impacts
Allowable environmental conditions
Temperature during use: -10°C to +45°C
Chemicals/liquids: Fresh water, salt water, perspiration, urine,
soapsuds, chlorine water
Moisture: Submersion: max. 1h in 3m depth, relative humidity: no
restrictions
Solids: Dust, occasional contact with sand
Clean the product after contact with humidity/chemic
als/solids, in order to avoid increased wear and tear and dam
age (see page10).
Prohibited environmental conditions
Solids: Highly liquid-binding particles (e.g.talcum), continuous
contact with sand
Chemicals/liquids: Acids, continuous use in liquid media
2.4 Lifetime
This product was tested by the manufacturer with 3million load
cycles. Depending on the user’s activity level, this corresponds to a
maximum lifetime of 5years.
Recreational sports: The maximum lifetime is 3years.
Competitive sports: The lifetime is 1 year.
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3 General safety instructions
CAUTION! Risk of injury and risk of product damage
►To prevent mechanical damage, use caution when working with
the product.
►Note the combination possibilities/combination exclusions in the
instructions for use of the products.
►Observe the maximum lifetime of the product.
►Check the product for damage and readiness for use prior to
each use.
►Do not expose the product to excessive strain (section: “Area of
application” see page7) or to prohibited environmental conditions
(see page7).
►Do not use the product if it is damaged or in a questionable con
dition. Take suitable measures (e.g.cleaning, repair, replace
ment, inspection by the manufacturer or a specialist workshop).
►Keep the product away from devices and items that are sensitive
to magnetic fields. (e.g.pacemakers, electronic devices, swipe
cards). The magnets in the product may affect or damage other
devices and objects.
►Pay attention to any information of the manufacturer regarding
magnetic fields (e.g.for a medical implant).
Signs of changes in or loss of functionality during use
Among other factors, changes in functionality can be indicated by an
altered gait pattern, a change in the positioning of the prosthetic com
ponents relative to each other and by the development of noises.
4 Scope of delivery
Quant
ity
Designation Reference number
1 Instructions for use –
1 Quickchange – base with lock
ing ring
4R11=R-3-2
4 Set screw 506G3=M8x14
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Spare parts/accessories
Designation Reference num
ber
Quickchange connection: Pyramid 4R11=P-1-1
Quickchange connection: Pyramid receiver 4R11=R-1-1
Quickchange connection: Threaded connector,
modular system
4R11=ST-1-1
Quickchange connection: Threaded connector,
modular system for children
4R11=ST-2-1
Pyramid receiver reduction 4X907=1
Set screw – 12mm 506G3=M8X12-V
Set screw – 14mm 506G3=M8X14
Set screw – 16mm 506G3=M8X16
5 Preparing the product for use
CAUTION
Incorrect alignment or assembly
Risk of injury due to damaged prosthetic components
►Observe the alignment and assembly instructions.
CAUTION
Improper assembly of the screw connections
Risk of injury due to breakage or loosening of the screw connec
tions
►Clean the threads before every installation.
►Apply the specified torque values.
►Follow the instructions regarding the length of the screws and
about how to secure the screws.
INFORMATION
Observe the alignment of the prosthesis for all combinations.

►Position the adapter in the prosthesis in a way that makes it easy
to adjust the structural height (e.g.close to the socket).
►Perform the “basic configuration,” “static alignment” and
“dynamic optimisation” steps for each prosthetic component
combination.
Aligning the adapter
The adapter connections can be aligned proximally or distally as
required (see fig.2). The anterior or posterior alignment of the
adapter is dependent upon its build height in the prosthesis. During
this process, the three balls of the locking mechanism are aligned in
different directions.
>Prerequisite: The adapter is connected and locked into place.
1) Carry out proximal/distal alignment of the adapter connections.
2) INFORMATION: A point on the base indicates the position of
each sphere.
Carry out anterior/posterior alignment of the adapter according to
the build height in the prosthesis:
→Below the knee joint: Align two of the balls in the posteri
or, align one ball (with the point) in the anterior (see fig.3).
→Above a prosthetic knee joint: Align two balls in the
anterior, align one ball (with the point) in the posterior (see
fig.4).
3) Carry out the prosthetic alignment.
4) For assembly above a prosthetic knee joint: Flex the prosthet
ic knee joint and check whether the adapter is touching the joint.
Take appropriate measures if they are touching, for example:
→Increase the distance between the adapter and prosthetic
knee joint.
→Insert a flexion stop.
Connecting the pyramid adapter and pyramid receiver
The pyramid adapter is fixed with the set screws of the pyramid receiv
er.
9
>Required materials: Torque wrench (e.g.710D20), Loctite241
636K13
1) When a component of the modular system for children is
connected: Insert reducer 4X907=1 into the pyramid receiver of
the Quickchange adapter.
2) Do not use Loctite during the fitting.
Fitting: Screw in and tighten the set screws.
Modular system for children: 9Nm
Modular system: 10Nm
3) Final assembly: Secure the set screws with Loctite and tighten
them.
Modular system for children: 9Nm
Modular system: Pull forward 10Nm, then tighten 15Nm
4) Replace set screws that are protruding or have been screwed in
too far (see page8).
Adjustment
The set screws of the pyramid receiver can be used to adjust the
alignment of the prosthesis.
Replacement and disassembly
To keep the position that was set using the set screws: Only unscrew
the two adjacent set screws that are screwed in the furthest.
6 Use
Both parts of the adapter can be pulled apart after they are unlocked.
After the prosthetic components are changed, the adapter is locked
once more.
INFORMATION
Sometimes the two parts of the adapter cannot be easily pulled
apart after unlocking. This can happen, for example, if you have not
unlocked the adapter for a long time; however, it can be easily cor
rected:
►Stand in a place where you can hold on tightly.

►Unlock the adapter. Lift the prosthetic leg slightly to the side and
then tap the floor with the inside of the prosthetic foot until the
adapter loosens.
>Prerequisite: The user is sitting or the prosthesis is not being
worn.
>Prerequisite: The adapter's parts are clean and free of dust or
sand.
1) Rotate the locking ring to unlock the adapter (see fig.5).
2) Pull apart both parts of the adapter.
3) Use a dry cloth to remove any soiling.
4) Make the change and plug the adapter back together.
5) INFORMATION: Help children to lock the adapter.
Rotate the locking ring to lock the adapter (see fig.5).
6) Retighten the locking ring slightly while the prosthesis is under
load.
7 Cleaning
CAUTION
Use of unsuitable cleaning agents or disinfectants
Impairment of functionality and damage due to incorrect cleaning
agents or disinfectants
►Clean the product only according to the instructions given in this
section.
►For the prosthesis, observe the cleaning instructions for all pros
thetic components.
Solids such as dust or sand can prevent the two parts of the adapter
from connecting and locking together. As a result, special attention
must be paid when removing dust and sand during cleaning.
Cleaning with water
1) Unlock the adapter and pull apart.
2) Either rinse both parts of the adapter with clean water or clean
with a damp cloth.
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3) Dry the parts with a soft cloth and leave to air dry.
Cleaning with compressed air
Oil-free compressed air can be used for in-depth cleaning, for
example while checking the prosthesis.
►Blow out the adapter with oil-free compressed air.
8 Maintenance
►A visual inspection and functional test of the prosthetic compo
nents should be performed after the first 30days of use.
NOTICE! The individual components of the Quickchange adapter
show signs of wear differently depending on frequency and intensity
of use. Always bring all of the components that can be connected to
each other for inspection.
►During regular inspection: Inspect the prosthesis for signs of
wear and check its function.
►Conduct annual safety inspections.
9 Disposal
Do not dispose of the product with unsorted household waste.
Improper disposal can be harmful to health and the environment.
Observe the information provided by the responsible authorities in
your country regarding return, collection and disposal procedures.
10 Legal information
All legal conditions are subject to the respective national laws of the
country of use and may vary accordingly.
10.1 Liability
The manufacturer will only assume liability if the product is used in
accordance with the descriptions and instructions provided in this
document. The manufacturer will not assume liability for damage
caused by disregarding the information in this document, particularly
due to improper use or unauthorised modification of the product.

10.2 CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on
medical devices. The CE declaration of conformity can be down
loaded from the manufacturer's website.
11 Technical data
System height and build height together with 4R11=R-3-2
System height [mm] Build height [mm]
4R11=P-1-1 44 44
4R11=R-1-1 91 55
4R11=ST-1-1 62 41
4R11=ST-2-1
(with 4X907=1)
62 (64) 41 (43)
Weight [g] Max. body weight [kg]
4R11=R-3-2 220 150
4R11=P-1-1 150 150
4R11=R-1-1 150 150
4R11=ST-1-1 110 150
4R11=ST-2-1 105 45
4R11=R-3-2, 4R11=P-1-1, 4R11=R-1-1, 4R11=ST-1-1: For use in a
sport prosthesis, the maximum body weight is 125kg
Material
4R11=R-3-2 Titanium/stainless steel
All connections Stainless steel
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© Ottobock · 647G1789=en_INT-02-2308
Template-Version: 2021-02 · FM478 · SB_148x105_IFU_ONLY_StructureParts
4R11=P-1-1, 4R11=R-1-1, 4R11=R-3-2, 4R11=ST-1-1
*) Body mass limit not to be exceeded!
For further details see manufacturer’s written instructions on intended use!
ISO 10328 – P7 – 150 kg*)
Ottobock SE & Co. KGaA
Max-Näder-Straße 15 · 37115 Duderstadt · Germany
T [phone] · F [phone]
[email protected] · www.ottobock.com